CLASS II Drug recall · Reported 1 Feb 2017 · FDA Enforcement Report
Amoxicillin for Oral Suspension USP, 125 mg recalled
Teva Pharmaceuticals USA is recalling Amoxicillin for Oral Suspension USP, 125 mg per, distributed in Puerto Rico. The recall was initiated on 21 Dec 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0440-2017
- FDA event ID
- 76038
- Recalling firm
- Teva Pharmaceuticals USA, North Wales, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Dec 2016
- FDA classified
- 24 Jan 2017
- Reported
- 1 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antibiotics
Timeline
| 21 Dec 2016 | Recall initiated by company | |
| 24 Jan 2017 | Classified by FDA | +34 days |
| 1 Feb 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotency: due to a low, out of specification test result for assay during stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73
Where it was distributed
United States and Puerto Rico
Questions about this recall
Why was it recalled?
Subpotency: due to a low, out of specification test result for assay during stability testing.
Which lots are affected?
Lot # 35432507A, 35434914A, 35435798A, 35437490A, Exp 9/19
Where was it sold?
United States and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Amoxicillin For recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amoxicillin for Oral Suspension USP, 125 mg recalled | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg recalled | West-Ward Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Amoxicillin for Oral Suspension, 125mg/, a) recalled | Dr Reddys Laboratories Tennessee | Mold | Nationwide |