Severity
Low
Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b) 90-count bottle (NDC 68001-322-05), For BluePoint Laboratories, Rx only, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788
Reported: September 26, 2018 Initiated: September 6, 2018 #D-1212-2018 26,496 bottles units
InvaGen Pharmaceuticals, Inc. issued this FDA Drug recall on September 26, 2018. Classified as Low severity (Class III). Approximately 26,496 bottles units are affected. The recall was issued because: Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic aci…. This recall notice is sourced from official FDA Drug enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Drug action (record #D-1212-2018) was formally reported on September 26, 2018, with the manufacturer initiating the action on September 6, 2018. It is classified under Low severity (Class III), with a current status of Terminated. InvaGen Pharmaceuticals, Inc. is listed as the recalling firm, operating out of Hauppauge, NY. Federal records indicate 26,496 bottles units are affected.
The documented reason for this recall is: Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size. Distribution data in the federal record shows the product reached: Product was distributed to 14 major distributors who shipped the product U.S.A. nationwide.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 8 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
26,496 bottles
Related Recalls
6
5 from same agency
Product Description
Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b) 90-count bottle (NDC 68001-322-05), For BluePoint Laboratories, Rx only, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788
Reason for Recall
Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.
Details
- Recalling Firm
- InvaGen Pharmaceuticals, Inc.
- Units Affected
- 26,496 bottles
- Distribution
- Product was distributed to 14 major distributors who shipped the product U.S.A. nationwide.
- Location
- Hauppauge, NY
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-1212-2018 |
| Date reported | September 26, 2018 |
| Date initiated | September 6, 2018 |
| Recalling firm | InvaGen Pharmaceuticals, Inc. |
| Units affected | 26,496 bottles |
| Distribution | Product was distributed to 14 major distributors who shipped the product U.S.A. nationwide. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b) 90-count bottle (NDC 68001-322-05), For BluePoint Laboratories, Rx only, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788. Recalled by InvaGen Pharmaceuticals, Inc.. Units affected: 26,496 bottles.
Why was this product recalled? ▼
Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 26, 2018. Severity: Low. Recall number: D-1212-2018.
Where was the recalled product distributed? ▼
Distribution: Product was distributed to 14 major distributors who shipped the product U.S.A. nationwide..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1212-2018) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Recall Guides
Learn how the US recall system works and how to protect yourself and your household.
How the US Recall System Works
The three federal agencies, how recalls are initiated, and what happens next.
Understanding Recall Severity Classes
What Class I, II, and III mean and which recalls demand immediate action.
What to Do When a Product Is Recalled
Verify, claim your remedy, report injuries, and navigate the process.
How to Check If Your Products Are Recalled
Step-by-step guide to checking food, products, medications, and vehicles.
Recalled Products in Your Home
A room-by-room household audit guide for active recalls.
Most Recalled Product Categories
Rankings of highest-recall categories from FDA, CPSC, and NHTSA.
Recall Context
Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. Recall severity varies based on the likelihood and degree of potential harm to consumers. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.
Related Safety Data
Explore related product safety and public health data from federal sources.
Food Safety Inspections
FDA and state food facility inspection results — violations, enforcement actions, and compliance history for food manufacturers and processors.
PlainFoodSafe →
Ingredient Safety Data
FDA food additive and ingredient safety database — regulatory status, usage limits, and safety assessments for thousands of ingredients.
PlainIngredients →
Nutrition Data
USDA nutrition facts for 2M+ food items — calories, macros, vitamins, and ingredient analysis to verify what you consume.
GetFoodFacts →
Drug Safety Information
FDA drug data for 680+ medications — interactions, alternatives, side effects, and safety information for recalled and active drugs.
PlainMeds →
Product Injury Data
CPSC emergency room injury data for 838 product categories — 7.3M NEISS records tracking real-world consumer product injuries.
PlainSafety →
Recall Checker
Search our database of 83K+ recalls by product name, brand, or recall number across all agencies.
Check Now →
Recall Radar
Live feed of the latest recalls across FDA, CPSC, NHTSA, and USDA — filter by agency and severity.
View Radar →
Nearby Recalls in This Category
Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
FDA Drug Moderate
Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., Indi…
Zydus Pharmaceuticals (USA) Inc · 2026-03-18
CPSC Moderate
Stoney Games Recalls Kluster Magnet Chess Games Due to Risk of Serious Injury or Death from Magnet Ingestion; Violates …
· 2026-03-12
FDA Drug Low
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, M…
Cipla USA, Inc. · 2026-03-11
FDA Drug Moderate
Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporati…
ACME UNITED CORPORATION · 2026-03-11
FDA Drug Moderate
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7, Manufactured for Dynarex Corp…
ACME UNITED CORPORATION · 2026-03-11
Compare this recall with Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, … →
Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).