Severity
Moderate
ModerateClass IIOngoing
FDA Drug recall · Reported May 13, 2026
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1¿ 19-gauge safety injection needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Di
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Teva Pharmaceuticals USA, Inc recalled Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Si… - a moderate-severity action.
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Si… was recalled by Teva Pharmaceuticals USA, Inc in May 13, 2026. Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Adm…. Check the official notice for the remedy. Verify recall #D-0519-2026 with the FDA Drug before acting.
The recall
Teva Pharmaceuticals USA, Inc issued this moderate-severity FDA Drug recall-Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Adm….
- Moderate
- severity level
- Class II
- classification
- May 13, 2026
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0519-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0519-2026) was formally reported on May 13, 2026, with the manufacturer initiating the action on April 24, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Teva Pharmaceuticals USA, Inc is listed as the recalling firm, operating out of Parsippany, NJ. Federal records list the affected scope as 2,200 kits.
The documented reason for this recall is: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. Distribution data in the federal record shows the product reached: Nationwide in the USA. 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.
Food recalls over time
Where this recall sits in its category - 25,126 food recalls on record
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.
Affected scope
2,200 kits
Related Recalls
6
0 from same agency
Product description
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1¿ 19-gauge safety injection needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Diluent Label: 0480-9263-21.
Reason for recall
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0519-2026 |
| Date reported | May 13, 2026 |
| Date initiated | April 24, 2026 |
| Recalling firm | Teva Pharmaceuticals USA, Inc |
| Firm location | Parsippany, NJ |
| Affected scope | 2,200 kits |
| Distribution | Nationwide in the USA |
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-0519-2026) 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? ▼
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1¿ 19-gauge safety injection needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Diluent Label: 0480-9263-21.. Recalled by Teva Pharmaceuticals USA, Inc. Units affected: 2,200 kits.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 13, 2026. Severity: Moderate. Recall number: D-0519-2026.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the USA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0519-2026) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
CPSC Moderate
Conair Recalls Over One Million Cuisinart Grill Brushes Due to Ingestion Hazard
· 2026-07-02
CPSC Moderate
Montessori Busy Board Toys Recalled Due to Risk of Serious Injury or Death from Magnet Ingestion; Violate Mandatory Sta…
Lesonic Technology Co., Ltd., dba Small Fish, of China · 2026-06-25
CPSC Moderate
Bada Boom Fireworks Recalls Pyro Diablo "Diablo Rising" Fireworks Due to Risk of Serious Injury or Death from Explosion…
· 2026-06-18
CPSC Moderate
Yamaha Recalls UMAX Bistro and Bistro Deluxe Vehicles Due to Injury Hazard
· 2026-06-11
FDA Food Critical
Butter Parsley Bagel Crisps, Item Number 18490, Net Weight: 10 lbs. Legacy Bakehouse, LLC, N8W22100 Johnson Dr., Wauk…
Legacy Bakehouse LLC · 2026-06-03
Compare this recall with Conair Recalls Over One Million Cuisinart Grill Brushes Due… →
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 May 13, 2026. 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.