PlainRecalls
ModerateClass IITerminated

FDA Drug recall · Reported March 12, 2014

a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Dist by Walgreen Company, 200 Wilmot RD Deerfield IL 60015 b) Family Wellness Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Distributed by Family Services Inc .10401 Monroe Road, Matthews, NC 28105 USA c) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 14 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS

Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the initial stability interval for Lansoprazole Delayed Release …

Recall #
D-1146-2014
Affected scope
58,656 Bottles
Initiated
January 3, 2014
Compiled from official public sources by the editorial team.
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Dr. Reddy's Laboratories, Inc. recalled a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules p… - a moderate-severity action.

a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules p… was recalled by Dr. Reddy's Laboratories, Inc. in March 12, 2014. Reason: Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observ…. Check the official notice for the remedy. Verify recall #D-1146-2014 with the FDA Drug before acting.

The recall

Dr. Reddy's Laboratories, Inc. issued this moderate-severity FDA Drug recall-Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observ….

Moderate
severity level
Class II
classification
March 12, 2014
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-1146-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Drug action (record #D-1146-2014) was formally reported on March 12, 2014, with the manufacturer initiating the action on January 3, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Dr. Reddy's Laboratories, Inc. is listed as the recalling firm, operating out of Princeton, NJ. Federal records list the affected scope as 58,656 Bottles.

The documented reason for this recall is: Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the initial stability interval for Lansoprazole Delayed Release Capsules. Distribution data in the federal record shows the product reached: Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Children & Baby Products recalls over time

Where this recall sits in its category - 3,731 children & baby products recalls on record

0100200300400500600 20052008201120142017202020232026 146
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

58,656 Bottles

Related Recalls

6

0 from same agency

Product description

a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Dist by Walgreen Company, 200 Wilmot RD Deerfield IL 60015 b) Family Wellness Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Distributed by Family Services Inc .10401 Monroe Road, Matthews, NC 28105 USA c) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 14 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895 d) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 28 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895 e) Equate Lansoprazole Delayed-Release Capsules USP, 15 mg Acid Reducer, 14 capsules per Bottle, and 28 capsules per bottle (Twin Pack)Distributed by Wal-mart Stores Inc. Bentonville, AR 72716 f) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 42 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895

Reason for recall

Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the initial stability interval for Lansoprazole Delayed Release Capsules.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number D-1146-2014
Date reported March 12, 2014
Date initiated January 3, 2014
Recalling firm Dr. Reddy's Laboratories, Inc.
Firm location Princeton, NJ
Affected scope 58,656 Bottles
Distribution Nationwide

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (D-1146-2014) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Drug before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Dist by Walgreen Company, 200 Wilmot RD Deerfield IL 60015 b) Family Wellness Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Distributed by Family Services Inc .10401 Monroe Road, Matthews, NC 28105 USA c) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 14 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895 d) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 28 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895 e) Equate Lansoprazole Delayed-Release Capsules USP, 15 mg Acid Reducer, 14 capsules per Bottle, and 28 capsules per bottle (Twin Pack)Distributed by Wal-mart Stores Inc. Bentonville, AR 72716 f) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 42 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 58,656 Bottles.
Why was this product recalled?
Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the initial stability interval for Lansoprazole Delayed Release Capsules.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 12, 2014. Severity: Moderate. Recall number: D-1146-2014.
Where was the recalled product distributed?
Distribution: Nationwide.
How do I check if my product is affected by a recall?
Check the product description and recall number (D-1146-2014) 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.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported March 12, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.